Is there a role of surgery in patients with recurrent or metastatic gastrointestinal stromal tumours responding to imatinib: A prospective randomised trial in China
Is there a role of surgery in patients with recurrent or metastatic gastrointestinal stromal tumours responding to imatinib: A prospective randomised trial in China
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DOI：
10.1016/j.ejca.2014.03.280
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发表时间：
2014-07-01
影响因子：
8.4
通讯作者：
Shi, Ying-Qiang
中科院分区：
文献类型：
--
作者：
Du, Chun-Yan;Zhou, Ye;Shi, Ying-Qiang
目的：对于对甲磺酸伊马替尼有反应的晚期胃肠道间质瘤（GIST）患者，手术的作用尚未得到正式证实。这项多中心随机对照试验的目的是评估是否手术治疗复发性/转移性GIST患者的残留疾病响应甲磺酸伊马替尼（IM）改善无进展生存期（PFS）相比，IM单独治疗。A组（手术治疗残留疾病）和B组（单独IM治疗）。在A组（19例患者）中，进行手术以尽可能完全切除残留的肉眼可见病变，术后继续IM治疗。在目标B（22例患者）中，IM以400 mg/天的剂量单独给药，直至疾病进展。主要终点是从IM开始之日起测量的PFS。本研究在ChiCTR注册中心注册，注册号为ChiCTR-TRC-00000244。结果：本随机试验因入组不良而提前关闭。仅入组了41例患者，而不是计划的210例患者。2-手术组的年PFS为88.4%，单用IM组为57.7%（P = 0.089）。中位总生存期（mOS）没有达到手术组和49个月的患者与IM单独的手臂（P = 0.024）。结论：虽然没有观察到显着差异，在两个手臂，这项研究表明，手术切除转移性病灶可能会改善晚期GIST患者的结果，并应刺激对这一主题的进一步研究。(C)2014爱思唯尔有限公司版权所有。
Objectives: For advanced gastrointestinal stromal tumour (GIST) patients who are responding to imatinib mesylate, the role of surgery has not been formally demonstrated. This multicenter randomised controlled trial was designed to assess whether surgery to treat residual disease for patients with recurrent/metastatic GISTs responding to imatinib mesylate (IM) improved progression free survival (PFS) compared with IM treatment alone.Methods: Between 3 and 12 months after starting IM for recurrent/metastatic GISTs, eligible patients were randomised to two arms: Arm A (surgery for residual disease) and Arm B (IM treatment alone). In Arm A (19 pts), surgery was performed to remove residual macroscopic lesions as completely as possible, and IM treatment continued after surgery. In Aim B (22 pts), IM was given alone at a dose of 400 mg per day until disease progression. The primary end-point was PFS measured from the date IM started. This study was registered in the ChiCTR registry with the ID number ChiCTR-TRC-00000244.Results: This randomised trial was closed early due to poor accrual. Only 41 patients were enrolled as opposed to 210 patients planned. 2-year PFS was 88.4% in the surgery arm and 57.7% in the IM-alone arm (P = 0.089). Median overall survival (mOS) was not reached in the surgery arm and 49 months in patients with IM-alone arm (P = 0.024).Conclusions: While no significant differences were observed in the two arms, this study suggests that surgical removal of the metastatic lesion may improve the outcome of advanced GIST patients and should stimulate additional research on this topic. (C) 2014 Elsevier Ltd. All rights reserved.